Medical examinations or other procedures conducted in the perineal area are typically performed with the patient's buttocks resting on the edge of an examination table, the patient's legs in stirrups, and the physician sitting on a chair between the patient's legs. The patient's position is usually such that the perineum is directly over the edge of the table, which allows full support of the weight of the lower body while allowing the physician good access.
Often there is a loss of blood or other body fluids during a procedure. Surgery, non-surgical gynecologic examinations conducted during menses, and other procedures all tend to spread body fluids or mixtures of body fluids and other fluids, such as rinses or topical anesthetics.
The table, on which the patient's buttocks rest, will become covered with body fluids as a result of drainage from the vagina, urethra, or anus. The fluids will drip over the edge and also seep under the buttocks by capillary action and will be smeared about by the patient's buttock movements. Fluids will run off waxed table paper and will soak through porous table paper. The commonly-used plastic-backed paper towels have limited soaking capacity and may not work well when draped vertically over a table edge.
Instruments, swabs, and other items used during the procedure become wetted with body fluids. They are quite likely to drip onto the floor or other surfaces when moved away from the patient's body for disposal or for temporary placement on a work surface.
The resulting mess is undesirable for several reasons.
First, current OSHA regulations called "universal precautions" mandate that health care workers collect, contain, and dispose of all bodily fluids/secretions.
Second, these OSHA regulations further mandate that any spillage of these bodily fluids be cleaned up accordingly in a specific manner after the procedure. This takes time which could be better spent, increases the interval between patients, and may require extra staff. Cleanup is also unpleasant and can be a hazardous task for health care workers. The dangers are slipping and falling, and possible infection with HIV virus or other disease agents present in the body fluid.
Third, the cleanup requires the use of strong chemical cleaners that kill HIV; the use of such cleaners is now mandated by OSHA regulations. The contaminated room is thus closed down and not usable for a period of time required for the chemical cleaners to decontaminate the cleansed surfaces. The cleaners leave an unpleasant odor. The next patient is liable to be offended or made nervous by the strong and unusual smell.
In gynecology the problems associated with menstruating patients lead to frequent re-scheduling of appointments when women begin menstruating at the time scheduled for the visit. The causes are patients' embarrassment, physicians' and nurses' concerns about HIV, and staff reluctance to clean up menstrual blood.
The ideal device to solve these problems would collect body fluids, prevent drips, and keep fluids from contact with the examination table. Such a device would be either disposable or easily cleaned and sterilized, and would protect health workers and reduce patient embarrassment.
Several prior art devices deal with collecting body fluids or with table-top or table-edge medical procedures.
U.S. patent to Kamm, U.S. Pat No. 3,199,507, discloses a blood loss measuring device used during obstetrical operations. This device is mounted on one end of the table top for positioning underneath the patient with a tube extending downward into a glass receptacle. The part of the device between the table top and the patient has no provision for receptacles to hold instruments, solutions, and the like. The portion of the device contacting the patient and channeling fluid flow is not rigid but appears to be made of a flexible fluid impervious web material.
Kamm's device is intended to measure blood loss volume, not to contain fluids; the containment is incidental, and no precautions are taken for reducing the spread of fluids or the number of items wetted. Six or seven different items will be contaminated with blood after its use, and each will need to be separately cleaned. Furthermore, Kamm's fluid impervious web 18 includes a peripheral dike 20 to contain fluids. There is no provision for preventing fluids from seeping under the patient's buttocks.
Mubeim, in U.S. Pat. No. 3,575,225, discloses a sterile specimen container comprising a rigid handle-rim-lid and a flexible transparent bag marked with gradations that attaches to the rim. The handle can be held in surgical operations or inserted between the patient and the surgical table (column 2, lines 20-24). The only receptacle is the flexible bag. There is no disclosure of additional instrument or solution bearing receptacles. Mubeim shows a tapered groove 18 which serves as a body fluid collecting channel (col. 5, line 16). The handle-rim-lid unit of Mubeim is not necessarily disposable. Thermosetting plastics, metal and fiberboard are the materials specified for it. At col. 5, line 3, injection molding for the rim/lid is taught; Mubeim does not teach stamping, and his device is not adaptable to stamping.
Nielsen, in U.S. Pat. No. 4,080,968, discloses a combination obstetrical support and receptacle for placement on a bed or other support surface. This device provides a work area positioned underneath the vagina that can also contain body fluids. A supporting surface, on which the woman's buttocks and lower back are supported during childbirth, is integrally formed with the work area. There are no provisions for additional instrument, equipment, solution or solid waste receptacles. Furthermore, Nielsen's device does not appear to be positioned at the edge of a support surface such as an examination table. It serves merely as a seat or support for the patient. The portion of Nielsen's device under the buttocks is not thin or planar.
Haswell, in U.S. Pat. No. 4,076,017, teaches an end portion 14 intended to be placed underneath the buttocks of the patient. Receptacles 18 and 23 are designed to collect amniotic fluid and blood from the patient during childbirth.
Philippi et al., in U.S. Pat. No. 2,739,858, disclose a self- leveling tray for operating tables. Philippi et al. further reveals in column 2, lines 45-50, that the tray can be used with certain obstetrical or examining tables where items such as instruments are accessible. There is no elaboration as to whether the instruments are meant to be large (such as monitors) or can be used for hand held medical instruments/implements; the tray may serve to accommodate both types of medical instruments.
Watson, in U.S. Pat. No. 4,266,669, discloses a disposable tray for use by anesthesiologists and for positioning at the end of an operating table. This disposable tray includes a central compartment for receiving the patients head and an arrangement of compartments and recesses for holding medical instruments and medications on both sides of the central compartment.
U.S. Pat. No. 4,160,505, issued to Rauschenberger, discloses a urethral catheterization tray that is provided as a sealed sterile, self-contained catheterization package. There are compartments for holding absorbent pads as well as an area for transferring urine collected in a drainage bag to a specimen container positioned in a recess provided in the tray. Spillage is contained (col. 2, lines 61-63).
Other U.S. patents are: U.S. Pat Nos. Des. 304,759 (McCloskey); Des. 322,855 (Tabuchi); Des. 323,560 (Boyce et al.); 3,646,938 (Haswell); 4,219,035 (Deconinck); 4,457,502 (Beach); 4,501,363 (Isbey, Jr.); 4,880,418 (Tramont); 4,936,836 (Weickgenannt); 4,968,013 (Kuck); 5,062,531 (Coy); 5,078,705 (Edwards et al.); 5,092,859 (Everett et al.); and 5,279,603 (Everett et al.)